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NCT ID: NCT01898455 Completed - Migraine Clinical Trials

Intranasal Cooling for Cluster Headache and Migraine

COOLHEAD
Start date: August 2013
Phase: N/A
Study type: Interventional

This study will be looking at the clinical efficacy of using a intranasal evaporative cooling device in providing relief of the symptoms of migraine and cluster headache. It will involve using a nasal catheter to spray a liquid coolant into the nasal cavity where it evaporates and removes heat from the tissue, thereby cooling the tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict and it is thought that this may provide symptomatic relief in both these forms of headache. 10 migraine patients and 5 cluster headache patients will be enrolled in the study and will receive 10 treatments each, for a maximum of 20 minutes at a time. They will be monitored during the treatment and for two hours afterwards to assess headache severity and side effects. There will be a further follow up 2 months after the last treatment to assess for longer term side effects from the treatment.

NCT ID: NCT01898364 Completed - Pompe Disease Clinical Trials

Safety and Efficacy Evaluation of Repeat neoGAA Dosing in Late Onset Pompe Disease Patients.

Start date: August 19, 2013
Phase: Phase 1
Study type: Interventional

Primary Objective: To evaluate the safety and tolerability of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients. Secondary Objective: To evaluate the pharmacokinetics, pharmacodynamics of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients. To evaluate the effect of neoGAA on exploratory efficacy endpoints in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients.

NCT ID: NCT01898351 Completed - Healthy Clinical Trials

Health Impacts of Sustainable Ingredient Selection in the Food and Drink Industry - ALTERNATIVE PROTEIN STUDY

Start date: March 2013
Phase: N/A
Study type: Interventional

Summary This research will examine the nutritional effects of supplementing diets with alternative plant sources of protein with potential to be grown in Scotland. In particular, we will assess the potential of these plant protein sources to complement diets in which the predominant source of protein is meat. These protein sources will include plants from the Fabaceae, Cannabaceae and Polygonaceae families, which could be used as the basis for the development of new foods. The research will assess if these plant proteins can deliver a comparable alternative to meat based diets. It is anticipated that the results could encourage increased consumption of plant products which would be favorable for consumers shifting away from animal-derived proteins for health and/or environmental reasons. Hypothesis: Consumption of protein rich plants could be a sustainable and healthy choice for partial replacement in predominantly meat based diets. Objective: The objective of this acute study is to assess satiety, postprandial effects, metabolite bioavailability and metabolism of single alternative proteins from a shortlist including buckwheat, fava beans, lupin, pea, and hemp in comparison with red meat. Study protocol Aims: To assess the impact of a pea, fava bean, lupin, hemp, buckwheat in comparison with meat in healthy people on: - Biomarkers of satiety as measured by gut-related hormones and subjective appetite using visual analogue scales, specifically to be collected during the meal over a three hour period, every 30 minutes. The energy intake measured for each volunteer after an ad libitum lunch (five hours after test meal). - Biomarkers of CVD risk including total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides and non-esterified fatty acids (NEFA). - Assessment of peripheral glycaemic control, fasting glucose, area under the curve combined with insulin data. - Plasma and urine markers of important phytochemical and protein metabolites will be quantitatively analysed to determine the systemic availability, in vivo concentrations and excretion times. - Volunteer views towards diets rich in plant proteins will be assessed.

NCT ID: NCT01898260 Completed - Myopia Clinical Trials

Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

Start date: August 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.

NCT ID: NCT01897571 Completed - Clinical trials for Primary Mediastinal Large B-Cell Lymphoma

Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL

Start date: June 13, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).

NCT ID: NCT01897532 Completed - Clinical trials for Diabetes Mellitus, Type 2

Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)

Start date: July 10, 2013
Phase: Phase 4
Study type: Interventional

The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a background of standard of care.

NCT ID: NCT01897350 Completed - Clinical trials for ST Segment Elevation Myocardial Infarction

Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial

Start date: July 2013
Phase: N/A
Study type: Observational

Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain functional and anatomical information on the heart. Several CMR parameters measured after primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated as the myocardial oedema minus infarct size; this again is a prognostic indicator following STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences available, with no standardisation of sequences used to assess this surrogate endpoint. The investigators propose to conduct a study to measure the myocardial oedema by all available techniques to determine the agreement between these methods.

NCT ID: NCT01897285 Completed - Clinical trials for Safety and Performance of Dressing Adhesive on Healthy Volunteers

A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing

Start date: May 2013
Phase: N/A
Study type: Interventional

AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a non-woven wound contact layer of Hydrofiber® (NaCMC). This dressing product was launched in 2012. A new source of silicone adhesive is now under assessment for this product. This Healthy Volunteer Wear test will form part of the Design Validation for this change in supplier and is required to confirm that the new Silicone Adhesive trilaminate supplier can coat the silicone adhesive to provide comparable adhesive dressing performance in terms of wear time, ease of use and with a similar safety profile in relation to the skin.

NCT ID: NCT01896726 Completed - Healthy Volunteers Clinical Trials

A Study of Baricitinib and Birth Control Pills in Healthy Females

Start date: July 2013
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to find out how the body absorbs and breaks down a common birth control pill called Microgynon when it is given with the study drug called baricitinib. Safety and the body's ability to tolerate baricitinib and Microgynon will also be studied. The study will last approximately 6 weeks for each participant.

NCT ID: NCT01896596 Completed - Hepatitis b Clinical Trials

Hepatitis B Vaccination in Infants

Infanrix
Start date: July 2013
Phase: Phase 4
Study type: Interventional

In the UK, infants currently receive a 5-in-1 vaccine (Pediacel) at 2, 3 and 4 months of age, which protects against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae type b (Hib). Infants also routinely receive a meningococcal group C vaccine (MenC) at 3 and 4 months and a 13-valent pneumococcal vaccine (Prevenar13) at 2 and 4 months of age. This study aims to offer infants a 6-in-1 vaccine (Infanrix-Hexa)that also helps protect against hepatitis B alongside the other routine vaccinations in the UK infant immunisation schedule and assess their immune responses to the different vaccines. Hepatitis B virus infects the liver and usually affects adults, but children can be infected through close contact with carriers of the virus. Children with hepatitis B infection may not have symptoms for many years but may go on to develop liver failure, cirrhosis and cancer. Many other countries already use Infanrix-Hexa and this study is being undertaken to help decide whether the UK can do the same. Babies taking part in this study will receive Infanrix-Hexa instead of Pediacel. All other vaccines given will be the same as in the routine schedule but will include one MenC vaccine instead of 2 doses because the UK infant immunisation schedule is soon going to change so that all babies will receive only one MenC vaccine at 3 months of age. There are currently several licensed MenC vaccines that can be given to babies. In order to check whether there are differences in protection, babies taking part will randomly receive one of 3 MenC-containing vaccines: NeisVacC, Menjugate or Menitorix. Studies have already shown that one dose of Neis-Vac or Menjugate given to babies at 3 months provides similar protection against MenC infection as two doses given at 3 and 4 months. Menitorix protects against both Hib and MenC, so babies in the group receiving MenitorixTM will have an extra dose of Hib which is also included in Infanrix-Hexa but might have a lower antibody response to MenC compared to the other two MenC vaccines, although all infants should be well-protected after their 12-month booster vaccinations, which also contain Menitorix.